Actively Recruiting
A Double-blind, Randomized, Placebo-controlled Trial Evaluating Saccharomyces Boulardii CNCM I-745 in Adults With Non-constipated Irritable Bowel Syndrome
Led by Biocodex · Updated on 2025-11-18
406
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of Saccharomyces boulardii CNCM I-745 on adults with non-constipated Irritable Bowel Syndrome (IBS). This study aims to compare the impact of this probiotic to a placebo on overall IBS symptoms using the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) after 8 weeks. The trial also evaluates quality of life improvements and safety in IBS patients over a 3-month treatment period. Participants will be randomly assigned to receive either Saccharomyces boulardii CNCM I-745 capsules, 250 mg twice daily, or placebo capsules at the same dose and schedule. This double-blind study will last about 13.5 months in total, with treatment lasting 3 months and various assessments at baseline, 28, 56, and 84 days. During the study, participants will complete symptom severity scales and quality of life questionnaires at regular intervals. Researchers will monitor safety through recording adverse events, changes in pulse rate, blood pressure, and body weight. The main outcome is the change in IBS symptom severity after 8 weeks, with additional evaluations over the full treatment period to assess response and tolerance.
CONDITIONS
Brief Title
Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 65 years
- Diagnosis of IBS of any subtype except constipation predominant (IBS-C) according to Rome IV criteria
- IBS Symptom Severity Scale (IBS-SSS) total score of 175 or higher at inclusion
- Able and willing to maintain nutrition habits during the study
- Able to understand, comply with study requirements, and provide written informed consent
- Women of childbearing potential must agree to use acceptable birth control methods during the study
You will not qualify if you...
- Diagnosis of constipation-predominant IBS (IBS-C) according to Rome IV criteria
- More than 5 bowel movements per day on average during screening
- Severe illnesses or gastrointestinal diseases other than IBS, including ulcers, coeliac disease, inflammatory bowel disease, bowel cancer, or infectious gastroenteritis
- History of abdominal surgery except for appendectomy, cholecystectomy, hemorrhoid surgery, or cesarean section more than 6 months before inclusion
- Familial colorectal cancer syndromes such as Lynch or Familial Adenomatous Polyposis
- Fecal transplant within 6 months before screening
- Use of prebiotics, probiotics, or synbiotics (except investigational product) within 2 weeks before screening
- Use of systemic antibiotics or antifungal treatments within 2 weeks before randomization
- Use of laxatives, antibloating agents, antidiarrheal medication, or antispasmodics within 2 weeks before screening (except loperamide as rescue medication)
- Regular use of non-steroidal anti-inflammatory drugs above low-dose aspirin within 2 weeks before screening and during the study
- Use of opioids or narcotic analgesics within 6 weeks before screening
- Treatment with two or more antidepressants, anxiolytics, or antipsychotics within 3 months before or during the trial
- Use of anticholinergic drugs for overactive bladder within 1 week before screening
- Allergy to yeast or Saccharomyces boulardii or known hypersensitivity to study components
- Presence of central venous catheter, critical illness, or immunocompromised status
- Rare hereditary metabolic disorders affecting sugar digestion
- Excessive alcohol use or drug abuse
- Other medical conditions interfering with study compliance or data interpretation
- Significant biological or clinical abnormalities incompatible with participation
- Pregnancy, breastfeeding, or risk of pregnancy without birth control
- Under legal guardianship or deprived of liberty
- Participation in another interfering clinical trial
- Health status not allowing informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants take either Saccharomyces boulardii CNCM I-745 or placebo capsules twice daily to evaluate effects on Irritable Bowel Syndrome symptoms.
Visits at baseline, day 28, and day 56
Duration - 4 weeks
Participants are monitored for continued effects and safety assessments after treatment ends.
1 visit at day 84
Trial Site Locations
Total: 10 locations
1
Hospital de Braga
Braga, Portugal
Actively Recruiting
2
Hospital da Luz
Lisbon, Portugal
Not Yet Recruiting
3
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Not Yet Recruiting
4
Hospital Universitario de León
León, Spain, 24008
Actively Recruiting
5
Hospital Universitario Gregorio Marañon & Centro de Salud Pavones
Madrid, Spain, 28007
Actively Recruiting
6
Hospital Clínico San Carlos
Madrid, Spain, 28040
Not Yet Recruiting
7
Hospital Universitario La Paz & Hospital Carlos III
Madrid, Spain, 28046
Not Yet Recruiting
8
Hospital Universitario Costa del Sol
Marbella, Spain, 29603
Not Yet Recruiting
9
Hospital Universitario Regional de Málaga
Málaga, Spain, 29010
Not Yet Recruiting
10
Hospital Universitario Central de Asturias & Centro de Salud la Lila
Oviedo, Spain, 33011
Not Yet Recruiting
Research Team
E
Elise Miclot
H
Hugo-Miguel Dachez De Oliveira
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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